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Room Alert Complies With FDA CFR 21 Regulations

The U.S. Food and Drug Administration (FDA) title 21 was recently revised in April of 2019. Room Alert meets FDA CFR 21 regulations that must be followed by restaurants, medical facilities, food storage, warehouses and more. Now that environment monitoring and environmental control is required to ensure food safety for employees, customers and the overall public, Room Alert is the ideal solution for your restaurants, food processing plants and more. Conditions that now need to be tracked include temperature and humidity, ventilation and air filtration and more. Regulating air quality helps businesses monitor for air pollutants, dust particles and other forms of contamination that can compromise the safety of food warehousing or other products.

What are the FDA regulations?

According to the FDA, “You must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms.” Additionally, industries that must comply with the FDA are also required to “document and maintain records of, environmental control and monitoring activities.” Luckily, proactive environment monitoring with Room Alert is here to help!

Why should you trust Room Alert?

AVTECH is the market leader in “IT & Facilities Environment Monitoring” and Room Alert is the most popular product for proactive environment monitoring worldwide. We offer all the monitors, sensors and accessories you would ever need to meet FDA environment monitoring regulations. We have over 30 years of industry expertise and countless awards to assure users that investing in the proper Room Alert monitors and sensors for your facility is an easy, affordable and dependable way to strengthen your business continuity plans and prevent costly downtime due to changes in your environment.

To align perfectly with the FDA requirements, we offer sensors for Temperature and Humidity, Flooding, Water Damage, Active Power, Smoke, Air Flow/ Air Quality, Room Entry, Motion and so much more. For higher capacity, more advanced safety and security, we recently launched our Room Alert 32S which provides:

  • HTTPS/SSL web interface
  • SSL/TLS email notifications
  • SNMP v1/V2c/v3
  • 2048-bit encryption
  • SSL push for data to reach the Room Alert Account online portal
  • Secure and advanced alerting via email, email-to-SMS, SNMP, JSON, HTTP Post, webpage update and more

Now with FDA regulations, businesses need to do more than implement environment monitoring. Organizations are also expected to maintain accurate and up to date records. In terms of keeping organized records to document activity, Room Alert continues to support your facilities. We offer reporting in Room Alert Account, our online monitoring dashboard that can be used to manage and monitor your Room Alert equipment from any internet-connected device. Reporting features in allow our users to graph their sensor data in concise and comprehensive reports to help detect trends and further prevent costly damage and downtime related to changes in the environment.

We also understand the importance of allowing business, facilities and organizations of all kinds customize their data retention as noted in this article we published recently. We previously talked about how according to the FDA, “An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.” We offer Room Alert Account plans designed to comply with FDA data retention regulations, so you can install Room Alert in your facilities and have peace of mind knowing you’re meeting the necessary requirements.

Room Alert is different from other environment monitoring platforms because our Room Alert Account services are available in fixed tiers as well as fully customizable options so you can ensure your business receives exactly what you need. If your business, facility or organization must comply with FDA regulations, then the Ultimate level of Room Alert Account Services would best suit your needs.

With Room Alert monitors starting at just $165, there is a Room Alert solution for every budget, and organizations of every size. We also have several industry bundle videos that can be a helpful resource to navigate what Room Alert products would be best for your situation, such as Food & Beverage. Install Room Alert now and have peace of mind tonight that you’re meeting industry regulations and getting the best proactive environment monitoring available.

Contact Us

If you have any questions or want additional information on how Room Alert products and Room Alert Account Services comply with industry regulations, please visit our YouTube Channel. You can email us at or visit our Contact page for a free consultation with one of our dedicated Senior Product Specialists today!

Room Alert is Made in the USA, ships the same day, and has been protecting facilities in over 185 countries since 1988.

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Example Polling Method Properties saved in Orion SolarWinds:

If you are using this client, you should configure the general SNMPv3 Credentials, but leave the Read / Write SNMPv3 Credentials section blank.

Room Alert Link- Supported Firmware Updates

Current S modelsCurrent E models
Room Alert 32SRoom Alert 32E
Room Alert 12SRoom Alert 12E
Room Alert 4E
Room Alert 3E

Room Alert Manager - Compatible Devices

The latest version of Room Alert Manager supports only the devices below.

It does not support any legacy Room Alert or TemPageR models.

Current S modelsCurrent E models
Room Alert 32SRoom Alert 32E
Room Alert 12SRoom Alert 12E
Room Alert 3SRoom Alert 4E
Room Alert 3E
Room Alert 3W